Congress Urges FDA to Better Police, Evaluate COVID-19 Antibody Tests
Members of Congress have called on the FDA to re-evaluate its stance toward COVID-19 antibody tests. Since mid-March, the agency has allowed diagnostic developers to bring their products to market without any outside evaluation that the results they produce are accurate, according to a report in FierceBiotech.
Instead, these manufacturers can proceed after validating the tests themselves, but they are not required to share those results. Companies must also print labels saying their antibody tests are not FDA approved or authorized and should not be used as the sole method to diagnose a coronavirus infection.
Several dozen diagnostic companies, many from China, have already taken the FDA up on this offer—notifying the agency of at least 140 different antibody tests that they intend to sell in the U.S. without seeking federal review. It is not known how many of these tests have been shipped or are available for purchase.